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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01009008
Registration number
NCT01009008
Ethics application status
Date submitted
5/11/2009
Date registered
6/11/2009
Date last updated
10/08/2018
Titles & IDs
Public title
Patient Activated Controlled Expansion (PACE) Trial
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Scientific title
Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation
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Secondary ID [1]
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CTP-0001
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Universal Trial Number (UTN)
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Trial acronym
PACE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Mastectomy
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Breast Reconstruction
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Patient Activated Controlled Expansion Device
Experimental: Post-mastectomy - Post-mastectomy patients undergoing expander reconstruction
Treatment: Devices: Patient Activated Controlled Expansion Device
Patient activated controlled expansion for post-mastectomy breast reconstruction
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Expansion to and maintenance of clinically desired breast volume (not exceeding implant maximum) until permanent implant placement or 6 months (whichever comes first) unless prohibited by a non-device related failure.
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Assessment method [1]
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Timepoint [1]
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6 months
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Secondary outcome [1]
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Safety as evidenced by a low incidence of device-related adverse events.
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Assessment method [1]
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Timepoint [1]
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6 months
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Secondary outcome [2]
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Time required to achieve desired expansion results.
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Assessment method [2]
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Timepoint [2]
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6 months
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Secondary outcome [3]
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Overall patient treatment satisfaction.
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Assessment method [3]
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Timepoint [3]
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6 months
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Secondary outcome [4]
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Overall surgeon treatment satisfaction.
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Assessment method [4]
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Timepoint [4]
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6 months
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Eligibility
Key inclusion criteria
1. Female between the ages of 18 and 65 years.
2. Planned breast reconstruction surgery post-mastectomy.
3. Able to provide informed consent.
4. Able to understand protocol components.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Tissue at the intended expansion site is determined unsuitable by the surgeon (i.e.,
infection, compromised vascularity, history of compromised wound healing, mastectomy
skin flaps of questionable viability, excessively tight skin envelope, previous
radiation treatment, active ulceration)
2. Residual gross tumor at the intended expansion site
3. History of or planned adjuvant radiation therapy
4. Co-morbid condition determined by the surgeon to pose unduly high risk of surgical
and/or postoperative complications.
5. Obesity with BMI of 30 or above
6. Current smoker
7. Psychologically unsuitable patient
8. Patient unable to understand the protocol for tissue expansion
9. Planned flight or assent to altitude exceeding 1000 meters above baseline during the
expansion period.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2013
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Sample size
Target
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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The Mount Hospital - Perth
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Recruitment postcode(s) [1]
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6000 - Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AirXpanders, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether a patient controlled tissue expander can
improve the results and patient experience in breast reconstruction. The study hypothesis is
that patient controlled expansion will lead to rapid and more comfortable outcomes than
historical precedents.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01009008
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Anthony Connell, M.D.
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01009008
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